- Confirmed objective response rate (cORR) of 75% overall and 93%
for the proposed Phase 3 regimen (zanidatamab + CAPOX/FP)
- Median duration of response (mDOR) of 16.4 months and median
progression free survival (mPFS) of 12 months
- Data support zanidatamab + chemotherapy as the foundation of a
potential new standard of care in first-line HER2-positive GEA
- Global randomized Phase 3 trial scheduled to launch in fourth
quarter (Q4) of 2021
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today announced
that new clinical data for zanidatamab, a HER2‑targeted bispecific
antibody, demonstrate promising response rates and durability in
first-line HER2-positive GEA. These data were presented today by
lead study investigator, Geoffrey Ku, M.D., Medical Oncologist at
Memorial Sloan Kettering Cancer Center (MSK), at the ESMO Annual
Congress.
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Phase 2 Study Results The data presented at ESMO are from
a clinical study of 36 patients with HER2-expressing GEA who
received zanidatamab in combination with either CAPOX
(capecitabine/oxaliplatin; n=14), FP (5FU/cisplatin; n=2), or
mFOLFOX6 (5FU/leucovorin/oxaliplatin; n=20). None of the patients
had received prior HER2-targeted therapies.
In 28 response-evaluable patients with metastatic HER2-positive
GEA, zanidatamab plus chemotherapy resulted in a cORR of 75% and
disease control rate (DCR) of 89% overall, with a cORR of 93% and
DCR of 100% in the proposed Phase 3 regimen of zanidatamab +
CAPOX/FP. All patients except one experienced a decrease in their
tumor size. The mDOR is 16.4 months and the mPFS is 12.0 months
across all treatment regimens with 61% of patients still on study
at the time of data cutoff.
In addition, the data demonstrate that zanidatamab plus
chemotherapy is generally well tolerated, with the majority of
treatment-related adverse events (TRAEs) considered mild to
moderate in severity (Grade 1 or 2). The most common grade ≥ 3 TRAE
was diarrhea which was manageable in the outpatient setting;
introduction of prophylactic loperamide reduced the incidence in
cycle 1 from 44% to 18%. No severe (grade ≥ 3) infusion-related
reactions or cardiac events were observed.
“Despite recent advances, metastatic HER2-expressing GEA has
high morbidity and mortality, and new treatment options are
desperately needed,” said the principal investigator on the trial,
Geoffrey Ku, M.D., Medical Oncologist at MSK. “The data presented
today at ESMO demonstrate the potential of zanidatamab in the
first-line setting, highlighted by response rates and durability
that compare favorably to the current standard of care as well as
to emerging treatments. These data support further evaluation of
zanidatamab plus chemotherapy in a randomized pivotal trial in
first-line HER2-positive GEA.”
HER2 is overexpressed in approximately 20% of GEA patients. For
these patients, Herceptin® (trastuzumab) is the only approved
HER2‑targeted therapy in 1L treatment, and therapeutic options are
currently limited if disease progression occurs. Zanidatamab’s
bispecific approach simultaneously binds two non-overlapping
epitopes of HER2, ECD2 and ECD4, resulting in multiple mechanisms
of action that provide potential therapeutic benefits beyond the
combination of two monoclonal antibodies.
“Herceptin and chemotherapy have been the standard of care in
first-line HER2-positive GEA for over 10 years. The data presented
today give us the confidence that we have developed a
next-generation HER2-targeted agent that has the potential to
provide patients with an improved option in this setting,” said
Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer.
“Based on these data, we will pursue a randomized, Phase 3 trial
with the aim of establishing zanidatamab as the foundational agent
of a new standard of care in first-line HER2-positive GEA.”
In addition to the Phase 2 study presented today, Zymeworks and
its partner, BeiGene, Ltd., are conducting a parallel open-label
Phase 2 clinical trial evaluating zanidatamab and chemotherapy in
combination with the PD-1 inhibitor, tislelizumab, in first-line
HER2-positive metastatic GEA. These results are expected to be
presented at a future medical conference.
Zymeworks plans to launch, with BeiGene, a randomized, global
Phase 3 study (HERIZON‑GEA-01) in Q4 2021. The study will evaluate
zanidatamab plus chemotherapy (CAPOX or FP) with or without
tislelizumab, versus standard of care (trastuzumab plus
chemotherapy), for first-line treatment of locally advanced,
unresectable, or metastatic HER2‑positive GEA.
“Our long-standing vision for zanidatamab has been for it to
become a best-in-class HER2‑targeted therapeutic that could address
the needs of a broad spectrum of patients with HER2‑expressing
cancers,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO.
“Over the years we have shared data that have showcased the
promising anti-tumor activity and safety profile of zanidatamab;
that said, the data shared today stand out as they represent the
first clinical validation of zanidatamab in a front-line setting.
As we embark on our second pivotal trial and prepare for
commercialization, these data represent a landmark moment for
zanidatamab and for Zymeworks.”
Dr. Ku has provided advisory services for Zymeworks.
ESMO Presentation The presentation will be available to
conference registrants on the ESMO conference website as well as to
the general public on the Zymeworks website at
https://www.zymeworks.com/publications The presentation will be
available to conference registrants on the Title: Phase (Ph) 2
Study of Zanidatamab + Chemotherapy (chemo) in First Line (1L)
HER2‑expressing Gastroesophageal Adenocarcinoma (GEA) Lead Author:
Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer Center, New
York, NY, US Abstract: 3678 E-poster: 1380P
Conference Call and Webcast The company will host a
conference call and webcast to discuss the updated data. The event
will be led by Ali Tehrani, Ph.D., Zymeworks’ President and CEO and
Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer, and
will include a presentation by medical oncologist and principal
investigator, Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer
Center. Dr. Ku and members of Zymeworks’ executive team will be
available to answer questions at the conclusion of the call.
Date: Thursday, September 16th Time: 7:30 am ET
Interested parties can access the live webcast via the
Zymeworks’ website at
https://ir.zymeworks.com/events-and-presentations. A recorded
replay will be accessible after the event through the Zymeworks
website.
About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks’
Azymetric™ platform, that can simultaneously bind two
non-overlapping epitopes of HER2, known as biparatopic binding.
Zanidatamab’s unique binding properties result in multiple
mechanisms of action including HER2-receptor clustering,
internalization, and downregulation; inhibition of growth
factor-dependent and -independent tumor cell proliferation;
antibody-dependent cellular cytotoxicity and phagocytosis; and
complement-dependent cytotoxicity. Zymeworks is developing
zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical
trials globally as a targeted treatment option for patients with
solid tumors that express HER2. The FDA has granted Breakthrough
Therapy designation for zanidatamab in patients with previously
treated HER2 gene-amplified biliary tract cancer (BTC), and two
Fast Track designations to zanidatamab, one as monotherapy for
refractory BTC and one in combination with standard of care
chemotherapy for first-line gastroesophageal adenocarcinoma (GEA).
These designations mean zanidatamab is eligible for Accelerated
Approval, Priority Review and Rolling Review, as well as intensive
FDA guidance on an efficient drug development program. Zanidatamab
has also received Orphan Drug designations for the treatment of
biliary tract, gastric and ovarian cancers, as well as Orphan Drug
designations from the European Medicines Agency for the treatments
of biliary tract and gastric cancer.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the development of next-generation multifunctional
biotherapeutics. Zymeworks’ suite of therapeutic platforms and its
fully integrated drug development engine enable precise engineering
of highly differentiated product candidates. Zymeworks’ lead
clinical candidate, zanidatamab (ZW25), is a novel Azymetric™
bispecific antibody which has been granted Breakthrough Therapy
designation by the FDA and is currently enrolling in a pivotal
clinical trial for refractory HER2-amplified biliary tract cancer
(HERIZON-BTC-01) as well as several Phase 2 clinical trials for
HER2-expressing gastroesophageal, colorectal, and breast cancers.
Zymeworks’ second clinical candidate, ZW49, is a novel bispecific
HER2-targeting antibody-drug conjugate currently in Phase 1
clinical development and combines the unique design and antibody
framework of zanidatamab with Zymeworks’ proprietary ZymeLink™
linker and cytotoxin. Zymeworks is also advancing a deep
preclinical pipeline in oncology (including immuno-oncology agents)
and other therapeutic areas. In addition, its therapeutic platforms
are being leveraged through strategic partnerships with nine
biopharmaceutical companies. For additional information about
Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on
Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and “forward-looking information” within the meaning of
Canadian securities laws, or collectively, forward-looking
statements. Forward-looking statements in this news release
include, but are not limited to, statements that relate to
Zymeworks’ clinical development of its product candidates, related
clinical trials, anticipated clinical data presentations, potential
therapeutic effects of zanidatamab, Zymeworks’ preclinical
pipeline, and other information that is not historical information.
When used herein, words such as “plan”, “expect”, “may”,
“potential”, “will”, “aim”, and similar expressions are intended to
identify forward-looking statements. In addition, any statements or
information that refer to expectations, beliefs, plans,
projections, objectives, performance or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking. All forward-looking statements
are based upon Zymeworks’ current expectations and various
assumptions. Zymeworks believes there is a reasonable basis for its
expectations and beliefs, but they are inherently uncertain.
Zymeworks may not realize its expectations, and its beliefs may not
prove correct. Actual results could differ materially from those
described or implied by such forward-looking statements as a result
of various factors, including, without limitation, market
conditions and the factors described under “Risk Factors” in
Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended June
30, 2021 (a copy of which may be obtained at www.sec.gov and
www.sedar.com). Consequently, forward-looking statements should be
regarded solely as Zymeworks’ current plans, estimates and beliefs.
Investors should not place undue reliance on forward-looking
statements. Zymeworks cannot guarantee future results, events,
levels of activity, performance or achievements. Zymeworks does not
undertake and specifically declines any obligation to update,
republish, or revise any forward-looking statements to reflect new
information, future events or circumstances or to reflect the
occurrences of unanticipated events, except as may be required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210916005389/en/
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com Jack Spinks (604) 678-1388 ir@zymeworks.com
Media Inquiries: Mary Klem (604) 678-1388
media@zymeworks.com
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